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NCT06587282 · ClinicalTrials.gov registry record · NA

PREEMIE: Study for Treatment of PDA in Premature Infants

A NA study of Patent Ductus Arteriosus (PDA), sponsored by Merit Medical Systems.

Recruiting
Registry status
NA
Development phase
55
Enrollment target
10
Study locations

NCT06587282: Recruiting NA study of Patent Ductus Arteriosus (PDA), sponsored by Merit Medical Systems.

NCT06587282 is a NA study of Patent Ductus Arteriosus (PDA) that is actively recruiting participants, run by Merit Medical Systems. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06587282, a NA study of Patent Ductus Arteriosus (PDA), is actively recruiting participants, sponsored by Merit Medical Systems.

RECRUITING
Registry status
NA
Development phase
55 participants
Enrollment target
10
Study locations

Study Summary

This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.

Primary Outcome

Composite rate of device-related Major Adverse Events (MAE) of interest through 30 days following the index procedure.

Interventions

  • DEVICE Bloom Micro Occluder System

Study Locations (10)

California

  • UC Davis Health - Sacramento
  • UC San Diego-Rady Children's Hospital - San Diego

Florida

  • Memorial Healthcare System-Joe DiMaggio Children's Hospital - Hollywood
  • Nicklaus Children's Hospital - Miami

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Missouri

  • Washington University-St. Louis Children's Hospital - St Louis

Ohio

  • Nationwide Children's Hospital - Columbus

Tennessee

  • Le Bonheur Children's Hospital - Memphis

Texas

  • UT Southwestern Medical Center - Dallas

Wisconsin

  • Herma Heart Institute-Children's Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2025-03-06
Est. Completion 2029-03
Phase NA
Merit Medical Systems

18 total trials

What NCT06587282 shows while recruiting

NCT06587282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Patent Ductus Arteriosus (PDA) appearing as the primary indexed condition, and to 1 intervention - of which Bloom Micro Occluder System is the first listed.

NCT06587282 lists 10 locations in 8 states (California, Florida, Georgia).

Frequently Asked Questions

What is clinical trial NCT06587282 about?

NCT06587282 is a clinical study titled "PREEMIE: Study for Treatment of PDA in Premature Infants". This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.

What is the current status of trial NCT06587282?

This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2025-03-06. Estimated completion is 2029-03.

What conditions does trial NCT06587282 study?

This clinical trial studies the following conditions: Patent Ductus Arteriosus (PDA).

What interventions are being tested in trial NCT06587282?

The interventions under investigation include: Bloom Micro Occluder System (DEVICE).

Who is sponsoring clinical trial NCT06587282?

This trial is sponsored by Merit Medical Systems, which has 18 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06587282 being conducted?

This trial has 10 study locations across California, Florida, Georgia, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06587282's enrollment target sits among peer trials

55 1264th of 2000 higher than 733 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06587282, the US trial registry maintained by the National Library of Medicine. NCT06587282 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.